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Evaluation of the effect of microneedling with tranexamic acid in combination with hydroquinone formula in comparison with either alone in the treatment of melasma

Evaluation of the efficacy, safety and reliability of the effect of microneedling with tranexamic acid, in combination with a hydroquinone topical formula, in comparison with any of the treatments alone in patients with melasma: A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220122053789N1
Enrollment
50
Registered
2022-02-13
Start date
2022-03-16
Completion date
Unknown
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma. Chloasma

Interventions

Intervention 1: Intervention group A: Patients use the Kligman-like topical formula on one side of the face every other day for 2 months and microneedling with 10% tranhexamic acid on the other side f

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 18 to 60 years old Clinical diagnosis of bilateral melasma of the cheek

Exclusion criteria

Exclusion criteria: Patients who have received any treatment for melasma in the past 1 month. Patients who have contraindications to tranexamic acid. (Includes known drug allergy, intracranial hemorrhage, known color vision disorder, history of arterial or venous thromboembolism or active thromboembolic disease, ischemic heart disease, and stroke) Patients with mental instability (which is expected to affect the study process). Patients who do not have informed consent to participate in the study. Patients who do not have the opportunity to visit regularly and cooperate for scoring and follow-up sessions.

Design outcomes

Primary

MeasureTime frame
Efficacy. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: By modified Melasma Area & Severity Index and Visual Analogue Scale.

Secondary

MeasureTime frame
Safety. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: Ask from the patient for possible adverse effects.;Satisfaction. Timepoint: One and two months after the start of treatment and one and four months after the end of treatment. Method of measurement: Based on patient scoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Goodarzi

Iran University of Medical Sciences

azadeh_goodarzi1984@yahoo.com+98 21 6651 7341

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026